Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
VOXIDEX is for ophthalmic use only. VOXIDEX must not be injected sub-conjunctively. The solution should not be introduced directly into the anterior chamber of the eye.
Prolonged use may induce antibiotic resistance with result of overgrowth of non-susceptible organisms, including fungi. If infection develops, discontinue use and institute alternative therapy. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including levofloxacin, particularly in older patients and those treated concurrently with corticosteroids. Therefore, caution should be exercised and treatment with VOXIDEX should be discontinued at the first sign of tendon inflammation.
Prolonged use of topical ophthalmic corticosteroids, as contained in VOXIDEX, may result in ocular hypertension/glaucoma. The intraocular pressure should be checked frequently while on treatment with VOXIDEX. The risk of corticosteroid-induced increase in the intraocular pressure is increased in predisposed patients (e.g. diabetes).
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision and/or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may be related to complications to cataract surgery, development of glaucoma and/or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids, as contained in VOXIDEX.
Topical ophthalmic corticosteroids, as contained in VOXIDEX, may slow corneal wound healing. Topical ocular NSAIDs are also known to slow or delay healing. Concomitant use of topical ocular NSAIDs and steroids may increase the potential for healing problems.
In those diseases causing thinning of the cornea or sclera, perforations have been reported to occur with the use of topical corticosteroids, as contained in VOXIDEX.
Fluoroquinolones as contained in VOXIDEX have been associated with hypersensitivity reactions, even following a single dose. Discontinue VOXIDEX if an allergic reaction occurs.
Prolonged use with VOXIDEX should be avoided as the immune system may be suppressed. No long term safety data is available for VOXIDEX.
VOXIDEX should not be used in patients under 18 years of age.
This medicine contains 0,0015 mg benzalkonium chloride in each drop (about 30 µl) which is equivalent to 0,05 mg/ml.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
No medicine interaction studies have been performed, and concomitant eye drops should be avoided.
The concomitant use of probenecid, cimetidine, or ciclosporin with levofloxacin altered some pharmacokinetic parameters of levofloxacin.
Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems.
CYP3A4 inhibitors (including ritonavir and cobicistat) may decrease dexamethasone clearance resulting in increased effects.
The safety of VOXIDEX in pregnancy and lactation has not been established.
VOXIDEX should not be used during pregnancy as there are no safety data.
Levofloxacin and dexamethasone, as contained in VOXIDEX, are excreted in human milk. VOXIDEX should not be used during breastfeeding.
There are no data on potential effects of VOXIDEX on fertility.
No studies on the effects on the ability to drive and use machines have been performed.
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.
In clinical studies, 438 patients have been treated with VOXIDEX. Ocular disorders (e.g. corneal oedema, eye irritation, abnormal sensation in eye, lacrimation increased, asthenopia, corneal disorder, dry eye, eye pain, ocular discomfort, uveitis, visual brightness, conjunctivitis) have been reported. These reactions can also be linked to the cataract surgery itself. No serious adverse event was related to study treatment.
| System organ class | Very common | Common | Uncommon | Rare | Very rare | Not known |
|---|---|---|---|---|---|---|
| Immune system disorders | Extra- ocular allergic reactions, including skin rash# | Anaphylaxis# | ||||
| Endocrine disorders | Depression of adrenal function$ | Cushing’s syndrome$, adrenal suppression$ | ||||
| Nervous system disorders | Headache*#, dysgeusia* | |||||
| Eye disorders | Ocular burning#, decreased vision and mucous strand#, increase of the intraocular pressure$ | Discomfort$, irritation$, burning$, stinging$, itching$ and blurred vision$ | Eye irritation*, abnormal sensation in eye*, ocular hypertension*, lid matting#, chemosis#, conjunctival papillary reaction#, lid oedema#, ocular discomfort#, ocular itching#, ocular pain#, conjunctival injection#, conjunctival follicles#, ocular dryness#, lid erythema#, photophobia#, allergic and hypersensitivity reactions$, delayed wound healing$, posterior subcapsular cataract$, opportunistic infections$, glaucoma | Conjunctivitis$, mydriasis$, ptosis$, corticosteroid- induced uveitis$, corneal calcifications$, crystalline keratopathy$, changes in corneal thickness$, corneal oedema$, corneal ulceration$, corneal perforation$ | ||
| Respiratory, thoracic and mediastinal disorders | Rhinitis# | Laryngeal oedema# | ||||
| Gastrointestinal disorders | Nausea*, tongue disorder* | |||||
| Skin and subcutaneous tissue disorders | Pruritis* | |||||
| General disorders and administrative site conditions | Face oedema$, administration site conditions$ | |||||
| Investigations | Increased intraocular pressure*+ |
+ >6 mmHg that means significant intraocular pressure increase.
* Reported with the combination of levofloxacin/dexamethasone.
# Reported with the use of levofloxacin.
$ Reported with the use of dexamethasone.
Increase of the intra-ocular pressure (IOP) and glaucoma may occur. The use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous IOP induced by steroids or with pre-existing high IOP or glaucoma). Children and elderly patients may be particularly susceptible to steroid-induced IOP rise (see section 4.4). Diabetics are also more prone to develop subcapsular cataracts following prolonged topical steroid administration.
Increase of the intra-ocular pressure induced by topical treatment with corticosteroids has been generally observed within 2 weeks of treatment (see section 4.4.).
Discomfort, irritation, burning, stinging, itching and blurred vision frequently may occur immediately after instillation. These events are usually mild and transient and have no consequences.
In diseases causing thinning of the cornea, topical use of steroids could lead to cornea perforation in some cases (see section 4.4).
Depression of adrenal function associated with systemic absorption of VOXIDEX may occur when the instillations are administered with a frequent dosing schedule.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to:
SAHPRA:
https://www.sahpra.org.za/health-products-vigilance/
Aspen Pharmacare:
E-mail: Drugsafety@aspenpharma.com
Tel: 0800 118 088
This medicine must not be mixed with other medicines.
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